Qms Specialist

We are hiring : Sr. Executive / Assistant Manager - Operational QMS (OSD Production QMS)

Work Location: Gagillapur, Hyderabad
Experience: 8 13 Years(OSD Only)
Qualification: B.Pharm / M.Pharm

Job Responsibilities:

• Implement and manage Quality Management Systems (QMS) in OSD Production (Granulation, Compression, Coating, Capsule Filling, packing).
• Initiation, Designing, Handle & closure of Deviations, Incidents, OOS/OOT, CAPA, Change Control, Risk Assessment (ICH Q9).
• Ensure compliance with USFDA cGMP requirements in USFDAapproved manufacturing plants only.
• Perform RCA using tools like Fishbone, 5Why, FMEA.
• Prepare, review, and maintain controlled documentation as per QMS standards.
• Support and face USFDA audits, regulatory inspections, and customer audits.
• Monitor data integrity (ALCOA+), GDP, and SOP compliance.
• Coordinate with Production, QA, QC, Validation, and Regulatory Affairs teams.
• Conduct GMP and QMS training for production personnel.
• Drive continuous improvement, compliance culture, and audit readiness.

Mandatory Requirements:

• Hands-on experience in USFDAregulated OSD manufacturing plants (mandatory).
• Strong exposure to initiation, preparation, handling and closure of OOS, OOT, Deviation & CAPA.
• Experience in audit responses, observations, and CAPA effectiveness checks.

Industry: Pharmaceutical / OSD Manufacturing (Only)
Function: Quality Management System (QMS) Production Support,

Send CV to: [email removed]